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Job Description The Oncology Regional Medical Scientific Director is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights. RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise. Location:<ul><li> This position covers the territory of New York City & Long Island, NY. Applicants must reside within the assigned territory. </li><li>Up to 50% travel required with some overnight.</li></ul> Responsibilities and Primary Activities: Scientific Exchange: <ul><li>Develops professional relationships and engages with national and regional SLs to ensure access to medical and scientific information on areas of therapeutic interest and Company products.</li><li>Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company</li><li>Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies</li><li>Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI)</li></ul> Research: <ul><li>Upon request from Global Center for Scientific Affairs (GCSA),</li><li>Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial</li><li>Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research</li><li>Identifies barriers to patient enrollment and retention efforts to achieve study milestones</li><li>Upon request from Global Clinical Trial Operations (GCTO),</li><li>Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.</li><li>Addresses questions from investigators and provides information regarding participation in company-sponsored clinical studies</li></ul>Scientific Congress Support:<ul><li>Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both internal and competitor data.</li></ul> Scientific Insights: <ul><li>Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients</li></ul> Required Qualifications, Skills, & Experience: Minimum: <ul><li>PhD, PharmD, DNP, or MD</li><li>Proven competence and a minimum of 3 years of immuno-oncology experience beyond that obtained in the terminal degree program</li><li>Ability to conduct doctoral-level discussions with key external stakeholders</li><li>Dedication to scientific excellence with a strong focus on scientific education and dialogue</li><li>Excellent stakeholder management, communication, and networking skills</li><li>A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers</li><li>Ability to organize, prioritize, and work effectively in a constantly changing environment</li><li>Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access)</li></ul> Desire to contribute to an environment of belonging, engagement, equity, and empowerment by: <ul><li>Working to transform the environment, culture, and business landscape</li><li>Leveraging diversity and inclusion to increase competitive advantage, per global diversity and inclusion strategy</li><li>Ensuring accountability to drive an inclusive culture</li><li>Strengthening the foundational elements of diversity</li><li>Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities</li></ul> Preferred: <ul><li>Field-based medical experience</li><li>Experience in Thoracic Malignancies</li><li> Research experience</li><li>Demonstrated record of scientific/medical publication</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #eligibleforERP Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $200,200.00 - $315,100.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 12/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R320329

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Oncology Regional Medical Scientific Director - Thoracic Malignancies - New York City & Long Island (Remote)

Job Description The Regional Medical Scientific Associate Director is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights. RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise. Location:<ul><li> This position covers the territory of New York City & Long Island, NY. Applicants must reside within the assigned territory. </li><li>Up to 50% travel required with some overnight.</li></ul> Responsibilities and Primary Activities: Scientific Exchange: <ul><li>Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products</li><li>Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company.</li><li>Addresses scientific questions and directs SL inquiries on issues outside of Regional Medical Scientific Director scope (e.g., grants) to appropriate company resources consistent with applicable policies</li><li>Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the Regional Medical Scientific Director's specific therapeutic area</li></ul> Research: <ul><li>Upon request from Scientific Affairs,<ul><li>Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial</li><li>Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research</li><li>Identifies barriers to patient enrollment and retention efforts to achieve study milestones</li></ul></li></ul><ul><li>Upon request from Global Clinical Trial Operations (GCTO),<ul><li>Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.</li><li>Protocol lead responsibilities in collaboration with GCTO</li><li>Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies</li></ul></li></ul> Scientific Congress Support: <ul><li>Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data.</li></ul> Scientific Insights: <ul><li>Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients</li></ul> Inclusive Mindset and Behavior: <ul><li>Demonstrates eagerness to contribute to an environment of belonging, inclusion, equity, and empowerment</li><li>Leads by example and serves as a role model for creating, leading, and retaining a diverse and inclusive workforce</li></ul> Position Qualifications: Education Minimum Requirement:<ul><li>PhD, PharmD, DNP, DO, or MD</li></ul>Required Experience and Skills:<ul><li>Proven competence and a minimum of 3 years of relevant therapeutic area experience beyond that obtained in the terminal degree program</li><li>Ability to conduct doctoral-level discussions with key external stakeholders</li><li>Dedication to scientific excellence with a strong focus on scientific education and dialogue</li><li>Excellent stakeholder management, communication, and networking skills</li><li>A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and</li><li>regulations relevant to the pharmaceutical industry and its customers</li><li>Ability to organize, prioritize, and work effectively in a constantly changing environment</li><li>Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote)</li><li>Familiarity with virtual meeting platforms</li></ul>Desire to contribute to an environment of belonging, engagement, equity, and empowerment by:<ul><li>Working to transform the environment, culture, and business landscape</li><li>Leveraging diversity and inclusion to ensure business value, per global diversity and inclusion strategy</li><li>Ensuring accountability to drive an inclusive culture</li><li>Strengthening the foundational elements of diversity</li><li>Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities.</li></ul>Preferred Experience and Skills:<ul><li>Field-based medical experience</li><li>Experience in Thoracic Malignancies</li><li>Research Experience</li><li>Demonstrated record of scientific/medical publication</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #eligibleforERP Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 12/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R320326

Oncology Regional Medical Scientific (Associate) Director - Thoracic Malignancies - New York City & Long Island (Remote)

Job Description Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection. Job description This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch. Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches. Principal Responsibilities<ul><li>Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:<ul><li>Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key Ofunctions.</li><li>Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.</li><li>Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).</li><li>Serve as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms.</li></ul></li><li>Oversee and serve as a technical integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis.</li><li>Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers</li><li>Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.</li><li>Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.</li><li>Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.</li><li>Maintain a high level of engagement in the program-specific design controls process and design history file development.</li><li>Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.</li><li>Enhance our Company's professional image and competitive advantage through publications, presentations, patents, and professional activities.</li></ul>Qualifications REQUIREMENTS:<ul><li>B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 10 years of combined experience in medical device and combination product development. Advanced degree is preferred.</li><li>5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product.</li><li>5+ years of leadership experience of managing complex device or combination product development programs and leading cross-disciplinary project teams.</li><li>Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy.</li><li>Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.</li><li>Proven track record of applying analytical skills in product design, development, and validation</li><li>Self-motivated with ability to work independently</li><li>Proven ability to lead team members of diverse skill sets and backgrounds</li><li>Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership</li><li>Excellent communication, presentation, negotiation, project management, and organizational skills</li><li>Experience with leading complex development projects at an enterprise level</li><li>Willing to travel</li><li>Able to multi-task continuously</li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $149,400.00 - $235,100.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/17/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328390

Principal Scientist - Device Technical and Engineering Lead (Director Equivalent)

Job Description P3 Rota E2E Job Description: The West Point ROTA E2E organization is seeking a highly motivated individual for the role of Senior Specialist, Engineering within the ROTA E2E Strategic Projects Technical Operations team. This role will provide end-to-end technical support for commercial vaccine products within the ROTA Organization. The incumbent will have the opportunity to contribute to the performance and results of multiple Vaccine manufacturing and Packaging areas by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions. Position Responsibilities<ul><li> The Senior Specialist, ROTA E2E Technical Operations, is responsible for leading and executing technical projects through all phases, including project planning, management, and execution. </li><li> Support, execute, and/or lead continuous improvement projects aimed at increasing compliance, simplifying, and standardizing processes, and gaining efficiencies. Works as an individual contributor, as part of a team, or as a project lead. </li><li> Complete and/or lead projects to enhance the performance of our processes. This includes investigating Corrective/Preventive Actions (CAPAs), initiatives aimed at improving Right-First-Time performance, reducing deviations, and value capture projects focusing on improving yield and efficiency, reducing costs, or lowering processing cycle times. </li><li> Manage project timelines to ensure compliance and customer deadlines are met. Escalates potential delays and develops remediation plans as needed. </li><li> Collaborate effectively with Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors. </li><li> Examine complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and effectively resolve the root causes. </li><li> Provide advanced technical support to manufacturing for complex problems and issues related to both processes and equipment. </li><li> Design, conduct, review, and approve experimental protocols as necessary, utilizing the Technical Operations lab facilities and/or full-scale production equipment. </li><li> Author, update, and review technical and manufacturing documents required for engineering studies and change controls. </li><li> Support regulatory inspection activities. </li><li> Provide on-the-floor support for complex operational and technical (process/equipment) issues. </li><li> Supports team objectives related to safety, environmental standards, and compliance. </li></ul> Education Minimum Requirement: <ul><li>Bachelor's degree in engineering or other equivalent technical field</li></ul> Required Experience and Skills: <ul><li>Minimum five (5) years post-bachelor degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance (or M.S degree with 3 years of experience)</li><li>Strong communication, collaboration skills, leadership, and ability to drive accountability.</li><li>Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.</li><li>Change control and/or project support role.</li><li>Demonstrated strong performance record and excellent project management skills.</li><li>Experience leading and managing departmental or cross-functional teams.</li></ul> Preferred Experience and Skills: <ul><li>Proficiency with pharmaceutical industry technical business processes such as: Change control author/reviewer, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.</li><li>Experience in technology transfer and/or start-up projects.</li><li>Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.</li><li>Regulatory inspection presentation experience with external regulatory authority representatives</li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/9/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328629

Senior Specialist, Project Engineering

Job Description The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of deviation management, equipment and automation systems, validation, and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus. Position Responsibilities: <ul><li> Serve as a subject matter expert for the Deviation Management team. Support and perform deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc. </li><li> Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and potential deviations. </li><li> Conduct real time investigations with the goal of fully understanding root cause and product impact </li><li> Manage projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, improve yield, reduce cost, or lower our processing cycle times </li><li> Manage investigation and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible including change control. </li><li> Support requests for regulatory inspections related to process overviews, investigations, projects, and validation. </li><li> Author updates to Master Batch Records and Standard Operating Procedures </li><li> Support team safety, environmental, and compliance objectives </li><li> Collaborate effectively with the area Managers, Operators/Technicians, support groups (e.g. EMU, Automation, Quality, and Planning). </li><li> Actively use and champion the use of Lean Six Sigma (LSS), our Company Production System, and digital tools both in problem solving and day-to-day operational activities. </li></ul> Minimum Education Requirement and Experience: <ul><li> Bachelor of Science (B.S.) in Mechanical or Chemical Engineering Degree or similar discipline with five (5) years' experience in support of Production, Process Engineering, Validation, Technical Services, or related experience; OR </li><li> Master of Science (M.S.) in Mechanical or Chemical Engineering Degree or similar discipline with three (3) years' experience in support of Production, Process Engineering, Validation, Technical Services, or related experience </li></ul> Required Experience and Skills: <ul><li> Minimum of 1-year experience in Deviation Management </li><li> Demonstrated ability to work both independently and as a part of a team. </li><li> Experience with regulatory agency interactions </li><li> Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills </li></ul> Preferred Experience and Skills: <ul><li> Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing </li><li> Experience with troubleshooting equipment and closed system processing </li><li> Experience with MIDAS, MEDs, SAP, PI, DeltaV, ProCal, TrackWise </li><li> LSS/MPS certification/experience </li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/26/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326815

Senior Specialist, Engineering

Job Description Director Manufacturing Operations (m/f/d) The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline. The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible for manufacturing biologics drug substance in an efficient and timely manner through application of state-of-the-art technologies for batch and continuous manufacturing with a Quality First, Safety Aways Mindset. The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology Transfer, Process Operations, and Support operations. The teams operate within a framework of regulatory compliance and established high standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Director Manufacturing Operations (m/f/d) shapes the direction of the pipeline by integrating an innovative / strategic focus and a high customer service level, fostering a strong performance orientation and effectively collaborating across the organization. He or she ensures a culture of self-direction, empowerment and accountability, while providing the support necessary to team members working in a widely cross-functional organization. The primary activities include but are not limited to the following activities: Leadership:<ul><li>Sets performance targets that align with business priorities and drives continuous improvement initiatives.</li><li>Develops the organization and culture (including values and behaviors such as empowerment, diversity, equity, and inclusion, accountability, trust, open communication)</li><li>Drives a talent agenda: leads people processes through recruitment, training, coaching and performance management to meet all operational requirements sustaining both global and local competitiveness and diversity.</li><li>Establishes robust succession plans and drives talent retention.</li><li>Builds and sustains strong networks in and outside the organization</li></ul>Management:<ul><li>Ensures that all aspects of operations within the facility comply with our compliance and safety policies and standards</li><li>Oversees planning and coordination of Manufacturing Operations activities including manufacturing and process technology transfers.</li><li>Designs and operationalizes technology transfer processes that deliver right first-time manufacturing of biologics to support the pipeline.</li><li>Manages the allocation of resources (including assets), costs and investments efficiently</li><li>Responsible for budgets and management of unit costs, capital investments and headcount</li><li>Contributes in his/her role within overarching business planning process driving towards fully integrated planning of clinical supply</li><li>Identifies and implements continuous improvement initiatives</li></ul>If you are passionate about leading innovative manufacturing operations and meet the qualifications listed, we encourage you to apply and join our dynamic team. Required Education, Experience and Skills: <ul><li>Bachelor's degree (B.S.) or equivalent in biology, chemical engineering, or a related discipline with at least 12 years or master's degree (M.S.) with at least 10 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry</li><li>Experience in drug substance manufacturing using mammalian cell culture, including upstream and downstream processing</li><li>Experience in leading cross-functional teams (Manager of Managers)</li><li>Working knowledge of cGMP regulations</li><li>Demonstrated supervisory and leadership skills</li><li>Excellent oral / written communication skills in English (C1), and German (B2)</li></ul>Preferred Experience and Skills: <ul><li>Qualification and training in economics and LEAN management</li><li>Experience with evolution of regulatory requirements</li><li>Experience with Cross-Functional Investigations and Root Cause Analysis Techniques.</li></ul>We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/10/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326868

Director Manufacturing Operations (m/f/d)

Job Description Senior Artificial Intelligence and Machine Learning (AI/ML) Data Scientist, Natural Language Processing The Senior AI/ML Data Scientist - Natural Language Processing (NLP) role involves helping to develop and deploy production-grade NLP products for unstructured and semi-structured data from across our company's research and development pipeline. These models and workflows will help solve real-world problems and contribute to Artificial Intelligence and Machine Learning (AI/ML) in therapeutic research and development. Key focus areas will include the scalable deployment of ML and Generative AI approaches (such as Large Language Models, or LLMs) for surfacing insights from proprietary unstructured research data and biomedical literature, as well as developing fit-for-purpose approaches for the likes of text classification, relation extraction, and entity linking. Additional job details: The types of datasets we focus on are both internal (e.g., electronic lab notebooks, safety reports, regulatory documents, clinical results) and external (e.g., public literature and Electronic Medical Records). In addition to new tool development, we often consult with some of our 5,000+ stakeholders (scientists, engineers, regulatory liaisons, data scientists, etc.) on their own projects, as well as additional stakeholders from across our multi-national company. We strive to enhance data science, NLP, and AI literacy across these groups. As part of our work, we have opportunities to coauthor presentations, reports, manuscripts, and/or public code releases. The position is embedded in a cross-disciplinary team of data scientists, bioinformaticians, and engineers that are all focused on using cutting-edge software, AI/ML, and data science techniques to drive drug discovery and development. Key Responsibilities: <ul><li> Building novel tools that enable the discovery, development, and delivery of new therapeutics to patients in need </li><li> Understanding real-world challenges and developing automated data solutions for them </li><li> Opportunities to directly interact with users of your data science, ML, and AI products </li><li> Evaluating, developing, testing, and deploying new techniques for natural language understanding </li><li> Freedom to propose projects that interest you and to collaborate cross-functionally on delivery </li><li> Staying updated on the newest methods in NLP, ML, and generative AI </li><li> Sharing the approaches you implement and their impact with internal company audiences and externally </li></ul>Education Minimum Requirement: <ul><li> Bachelor's degree with 5 years industry experience focused on NLP, data science, AI/ML/LLM engineering, computer science, semantic engineering or a related discipline. </li></ul>Required Experience and Skills: <ul><li> Minimum of 2 years experience with Python, Spark, or related frameworks in AI, machine learning, data science, data engineering, or similar context </li><li> Minimum of 1 years experience with Natural Language Processing, Generative AI, or related techniques for machine understanding of natural language (i.e., written text, omics data, or similar). </li></ul>Preferred Experience and Skills:<ul><li> A PhD in data science, AI/ML/LLM engineering, computer science, semantic engineering or a related discipline is preferred </li><li> M.S. with 2 years industry experience is preferred. </li></ul><ul><li> Fluency in Python programming, version control and collaboration with git, environment management (e.g., poetry, conda, docker), standard Python packages (e.g., pandas, numpy, matplotlib), and at least one ML framework (e.g., pytorch, tensorflow, fairseq) </li><li> Experience with scalable data engineering frameworks such as Apache Spark and orchestration frameworks such as Airflow, and/or experience with semantic search and retrieval frameworks (e.g., development and benchmarking of embedding models and retrieval approaches in the context of Retrieval Augmented Generation, RAG). </li><li> Experience with ML model deployment and operations (e.g., DevOps, MLOps, LLMOps), including CI/CD workflows and tooling (e.g., Github actions) </li><li> Experience with standard operations on non-relational (e.g., Elasticsearch/Opensearch, MongoDB, Neptune), relational databases (e.g., PostgreSQL), and vector databases (e.g., pgvector, Elasticsearch dense vectors) and deployment of APIs and web applications (e.g., flask, fastAPI, django, or dash) </li><li> Working knowledge of statistical learning, such as supervised, unsupervised, and weakly supervised learning, particularly in NLP contexts. </li><li> Working knowledge of NLP and/or Generative AI libraries (e.g., regular expressions, spacy, langchain), text annotation tools, and/or semantic frameworks (e.g. RDF triplestores, property graphs, ontology management). </li><li> A demonstrated ability to engage cross-functional teams and stakeholders, including an eagerness to acquire a level of domain knowledge </li><li> Excellent communication, teamwork, didactic, and leadership skills, including skills for scientific communication (authoring scientific articles and presenting) and guidance and mentorship of junior employees and less experienced collaborators </li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $122,800.00 - $193,300.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management, Waterfall Model Preferred Skills: Job Posting End Date: 12/25/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328969

Senior AI/ML Data Scientist - Natural Language Processing (NLP)- Remote

Job Description Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals&reg;, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability, and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. Our Animal Health Marketing team takes a customer centric perspective using customer feedback and market intelligence data. Using this data, we design, develop and deploy products, platforms, brands and marketing initiatives that ensure we can improve the health and well-being of animals everywhere. Our role The Companion Animal Business unit leads strategy development and drives business activation across markets throughout the world. It drives global marketing strategies and activities to drive successful key company Companion Animal launches and maximizes the value of in-line products. Our company has a very robust pipeline of new products and initiatives providing customer benefits and driving business growth. In this position, the Business Activation Lead is responsible for making the most business impact and value generation by working with regional leadership. You will lead priority business drivers, and the development of regional and country roadmaps. The Business Activation Lead will represent Global Companion Animal Marketing in its entirety to Regional Vice Presidents, General Managers, and marketing leadership. Through proven skills and influence, the candidate aligns regional management by planning and driving successful strategic launches of major new innovative products. Incumbent must have ability to influence franchise campaigns, customer engagement, and sales enablement to capture the most value of launches at customer level. Your efforts will be aligned with strategic guidance set at franchise level, initiatives provided by customer marketing, and integrating region/key market needs in the development of promotional and tactical implementation plans to execute across various target audiences. This position is an essential and prominent leadership position and will interact and influence all levels of the company as needed (including Senior Executives) to ensure optimized investments and successful Companion Animal strategic launches. Primary Activities include, but are not limited to: <ul><li>Drive marketing strategy for new products and cross-portfolio initiatives through assigned region.</li><li>Develop regional and key market alignment in support of priority business drivers,</li><li>Lead Regional and Country roadmap process and create Marketing Implementation Plans to maximize revenue.</li><li>Direct and monitor marketing investments to Pet Owners identify areas to improve efficiency and return.</li><li>Oversee and implement Regional Marketing training to ensure regional consistency.</li><li>Coach Business Unit directors on promotional expense optimization.</li><li>Organize necessary follow-up and task force with the regional and global teams to ensure successful delivery of the aligned objectives for the year.</li><li>Work with the Digital enablement department and the regional and local marketing teams to develop customer journeys and omnichannel operational strategy to reach identified targets.</li><li>Communicate, collaborate, and align actions with key stakeholders within regional commercial organizations including Vice Presidents/General Managers/Business Unit Directors on core marketing launch strategies and address local launch and post-launch needs.</li><li>Provide marketing team leadership to ensure successful implementation to support product launches throughout the world.</li><li>Collaborate closely with customer marketing, commercial, digital, and sales enablement and provide impactful launch materials to be implemented and adapted within markets.</li><li>Understand how the digital platforms and products are performing and drive iterative change as necessary to drive measurable results.</li><li>Orchestrate Business steering process to track implementation of key launches.</li><li>Collaborate with markets and regional management for new product demand requirements.</li><li>Coordinate with supply chain to ensure alignment and prioritization of material availability to support market launches.</li><li>Contribute to global annual marketing communications plans and budget planning cycle.</li><li>Collaborate and partner with regions, markets, and customers to gain insights.</li><li>Share learnings with the Global, local teams, and internal partners.</li><li>Understand and use key sources of information.</li><li>Support the development of marketing capabilities within market organizations.</li></ul>The successful candidate will initially be based in the USA for a period of approximately seven months before being transferred to our subsidiary office in São Paulo, SP, Brazil Main requirements: <ul><li>Bachelor's Degree in related areas of study</li><li>10 years of relevant work experience</li><li>Master's Degree or Advanced degree in marketing, advertising, sales communications, or promotion is preferred;</li><li>Excellent English communication skills, both written and spoken;</li><li>Portuguese and Spanish communication skills, both written and spoken are needed;</li><li>Strong life science, Veterinary medicine, animal science, medical marketing and business experience is highly preferred;</li><li>Broad work experience in marketing (communications, brand, product, channel, operational) and related sales support activities;</li><li>Successful track record to create the best performing positioning, campaigns and tactical communication initiatives targeting medical professionals and consumers;</li><li>Proven marketing experience of successful product launches with measured results with set of clear metrics;</li><li>Good acumen of digital marketing planning and operational execution, customer engagement, sales engagement, information technology, and operating within regulated industries;</li><li>Excellent ability to manage workflow with regional and local markets;</li><li>Familiarity of the Animal Health industry or related industry, marketing, and commercial Operations;</li><li>Managing and executing the product and launch communication plans;</li><li>Monitoring performance metrics including revenue, pricing, forecasting, sales cycle, markets, and sales opportunity targets;</li><li>Business Unit Director or Country Management leadership experience with P&L management is preferred.</li><li>Interpersonal skills that will help in developing and building strong internal and external relationships with key stakeholders to collaborate and drive results for business unit.</li><li>Ability to challenge and drive the organization towards the success of a project.</li><li>Ability to work in matrix organization and work with people across multiple time zones, functions, and locations.</li><li>Excellent written and verbal communication and presentation skills.</li><li>Good collaborator with the ability to develop high quality working relationships both internally and externally.</li><li>Flexibility to support launches across multiple regions throughout the world when necessary.</li><li>Able to travel up to 40% of time to different countries within assigned region.</li></ul>We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. #BRAnimal Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $181,600.00 - $285,800.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 12/27/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328977

Companion Animals Business Activation Lead, LATAM

Job Description The Human resources Tech Talent and Global Talent Acquisition (GTA) Sr Specialist role has responsibility for supporting the ongoing management of our Company's Human Resources technology solutions related to Talent and Global Talent Acquisition processes. This position will have a focus on the Talent area specifically. This position works closely with Process and Solutions leads within HR Technology as well as the Global Centers of Excellence (COE's). The Senior Specialist will support the Workday and supporting vendor systems as well as assess and manage new demand for business requests and identify/recommend alternative solutions related to these functional areas. This role operates in a complex and matrixed environment and is expected to apply HR functional and technical expertise to drive performance. The ideal candidate will be an accomplished human resources team member with project or operational team experience working globally. Responsibilities <ul><li>Support our Company's Talent and Global Talent Acquisition technology environment with a focus on the Workday system including configuration, testing and support.</li><li>Authors or facilitates the creation of functional or data integration requirements to effectively enable solutions and partners with infromation technology on implementation</li><li>Supports data privacy processes required to be followed as part of system changes and works with Data Privacy Office and data steward to ensure Local and Global Data Privacy and works council approvals are obtained, as required</li><li>Works with solutions, operations and Center Of Excellence leads to define the testing strategy, develops test plans/scripts, and executes and/or facilitates user testing</li><li>Executes changes as required to support ongoing demand based on priorities and assesses the impact of bi-annual system updates. Serves as subject matter expert to consult with end-users on appropriate system processes and procedures.</li><li>Participates in projects and programs where functional processes are impacted, inclusive of mergers, acquisitions, and divestitures</li><li>Partners with the solution leads, global centers of excellence and Information Technology to enable the evolving technology ecosystem</li></ul> Required Skills and Experience <ul><li>Bachelors degree with a minimum of 3 years of progressive experience in an HR/HRIS/IT/Operations function required. Master's degree, minimum of 4 years' experience required.</li><li>Minimum of 6 years of progressive experience in an HR/HRIS/IT/Operations function.</li><li>Ability to quickly assesses business needs to identify opportunities where HR/HRIS processes or systems can further the strategy, or streamline processes</li><li>Workday functional knowledge (Talent, Recruiting- with focus on Talent). </li><li>Ability to translate end-user requirements into technical functionality and vice versa. </li><li>Ability to thrive in a fast-paced environment with multiple priorities. </li><li>Ability to act as a change agent and lead others through change. </li><li>Ability to work independently and within a team and direct the resolution of highly complex or unusual business problems and translate HR/HRIS issues clearly and articulately into business terms</li><li>Juggle multiple priorities and manage expectations of different users and client groups. </li><li>Effectively communicate system capabilities and opportunities while demonstrating understanding of client needs and requirements.</li><li>Knowledge of Talent and Recruiting (focus on Talent) systems, processes and program knowledge</li><li>Project leadership expertise, managing in a deadline-driven environment</li><li>Initiative, creativity, with strong written and verbal communication skills</li><li>Excellent analytical, technical, problem-solving skills</li><li>Demonstrated competencies in relationship management, facilitation, influencing skills, and working globally as well as cross-functionally</li><li>A team-oriented style and a collaborative approach to getting work done. Ability to be hands-on and entrenched in the details when necessary </li><li>Ability to seek direction when needed as well as in working independently / self-directed with limited and/or an evolving set of available information</li><li>Strong understanding of and appreciation for data privacy concepts and principles (e.g., importance of securing data at rest and in transit, ensuring data is used in a way that is consistent with the intended purpose).</li></ul> Preferred Experience and Skills <ul><li>Human Resources Business Process improvement experience</li><li>Vendor Relationship Collaboration/Management</li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $101,100.00 - $159,100.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 01/3/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328360

HR Technology Talent & Global Talent Acquisition Senior Specialist

Job Description The Specialist - Quality Control, within Laboratory Operations, under the broad direction from the Associate Director, will be responsible for the implementation and management of laboratory equipment and automated systems utilized within assigned laboratories. The incumbent assures operation in accordance with our Manufacturing Division and Company safety policies and procedures, cGMP regulations, and within the departmental budget. Responsibilities can include providing technical expertise and recommendations on Company, Divisional and Organizational projects such as capital requests, operational improvements, instrument repair, SDLC and IOQ documentation and execution, and run the business activities in support of all testing conducted within LO. Responsibilities:<ul><li>Provides technical support as needed to other testing sites within our network including partnerships with sites in Durham, NC and Haarlem, NL to help ensure operational alignment of test methods and equipment including support for analytical method transfers.</li><li>Supports capital projects and coordinate equipment projects for assigned area within Laboratory Operations.</li><li>Works directly with the Engineering, Maintenance and Utilities team to prioritize and schedule preventative and corrective maintenance.</li><li>Initiates new equipment and instrument change control, SDLC and IOQ documentation and executes accordingly.</li><li>Initiates and participates in equipment related investigations and quality notifications to ensure compliance with cGMPs and regulatory requirements to support the quality, safety, efficacy, and</li><li>potency of our products.</li></ul>Education Minimum Requirement: <ul><li> High school diploma.</li></ul>Required Experience and Skills: <ul><li>A minimum of 1 year of experience in relevant laboratory, manufacturing, biotechnology or quality control experience in a related field.</li><li>Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment</li></ul>Preferred Experience and Skills:<ul><li>Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.</li><li>BS/B.A or M.S in Biology, Biochemistry, Chemistry, Engineering, Microbiology, Virology or another associated field. </li><li>Demonstrated technical experience in analytical testing methodology, equipment and/or software validation principles.</li><li>Speaks with courage and candor.</li><li>Strong written and verbal communication skills.</li><li>In-depth working knowledge and application of GMPs/GLPs.</li><li>Ability to manage multiple projects simultaneously.</li></ul>MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/23/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R327476

Specialist Quality Control

Job Description Assoc. Director of Support Operations (m/f/d) The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline. The Assoc. Director of Support Operations (m/f/d) will be a member of the Biotech Manufacturing Leadership team, reporting to the Head of Manufacturing. The successful candidate will lead the support teams including Material management in the GMP shop floor area, Solution Supply execution and a team of delivering excellence in the Manufacturing Operations Organization. This person will be a key stakeholder in the maintenance of the multiproduct strategy and will have a leadership role in the introduction of new processes, materials, and technologies to the facility as well as transfer of processes out. The Assoc. Director of Support Operations (m/f/d) has a variety of key responsibilities. These responsibilities include: <ul><li> Leading a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-clinic. </li><li> Overseeing the coordination efforts for Material Weight and Dispense, Solution Supply execution to meet Drug Substance Manufacturing Execution (Process Operations) requirements of New Product Introduction (NPI) schedule. </li><li> Management of the team for Operational Excellence, Technology Excellence, Innovation Excellence and Business Excellence which includes hiring and building team capabilities to meet the facility's operational requirements. </li><li>Overseeing the material management activities for the GMP areas, interfacing with the Supply Chain team and warehouse team and establishing standards for business processes associated with materials such as Kanban and VMI.</li><li> Embedding a culture that aligns with the Ways of Working and is committed to both facility and site priorities. </li><li> Overseeing production planning and associated activities, integrated with the Multiproduct platform. </li><li> In partnership with the Assoc. Director of Process Operations, championing the implementation of the lights-out manufacturing philosophy. Establishing a working rhythm that allows for agility and movement of staff between Drug Substance Fed Batch and Continuous Manufacturing, and Solution Supply. This includes designing a flexible skill matrix for training aligned with the working rhythm. </li><li> Ensuring operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA). </li><li> As applicable to Solution Supply and Weigh and Dispense, accountable for the management of the Production Alarm System, Sample Management Processes, Change approver for MES, Delta V Recipes, and material BOMs . </li><li> Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network partners for a common approach. </li><li>Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch. </li><li> Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally. </li></ul> The successful applicant will have the following education, skills, and experience: <ul><li> Degree level qualification in science or engineering, with People Manager Experience . </li><li> Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems. </li><li> Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage. </li><li> Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage. </li></ul>We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/10/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326869